Back to resultsSafety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bimatoprost /timolol formulation A fixed combination ophthalmic solution
bimatoprost/timolol fixed combination ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Patient has ocular hypertension or glaucoma in both eyes
- Requires IOP-lowering therapy in each eye
Exclusion Criteria:
- Active or recurrent eye disease that would interfere with interpretation of study data in either eye
- History of any eye surgery or laser in either eye within 6 months
- Required chronic use of other eye medications during the study
- Anticipated wearing of contact lenses during the study.
- Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bimatoprost/timolol formulation A
bimatoprost/timolol fixed combination ophthalmic solution
Arm Description
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
Secondary Outcome Measures
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01177098
Brief Title
Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
561 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost/timolol formulation A
Arm Type
Experimental
Arm Description
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
Arm Title
bimatoprost/timolol fixed combination ophthalmic solution
Arm Type
Active Comparator
Arm Description
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost /timolol formulation A fixed combination ophthalmic solution
Intervention Description
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost/timolol fixed combination ophthalmic solution
Other Intervention Name(s)
GANFORT®
Intervention Description
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Description
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame
Baseline, Week 12
Title
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Description
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Time Frame
Week 2
Title
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Description
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Time Frame
Week 6
Title
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Description
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Description
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame
Baseline, Week 12
Title
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Description
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has ocular hypertension or glaucoma in both eyes
Requires IOP-lowering therapy in each eye
Exclusion Criteria:
Active or recurrent eye disease that would interfere with interpretation of study data in either eye
History of any eye surgery or laser in either eye within 6 months
Required chronic use of other eye medications during the study
Anticipated wearing of contact lenses during the study.
Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
Sydney
State/Province
New South Wales
Country
Australia
City
Brno
Country
Czech Republic
City
Leipzig
Country
Germany
City
Budapest
Country
Hungary
City
Tel Aviv
Country
Israel
City
Saint-Petersburg
Country
Russian Federation
City
Valencia
Country
Spain
City
London
State/Province
England
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24667994
Citation
Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
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